The QA Operations Specialist II – Floor Support D Shift (Wed – Sat) 3:30 PM till 2:00 AM
Core
Provide on-the-floor Quality Assurance oversight for manufacturing and visual inspection of clinical and commercial drug products in a GMP facility.
Role type
Senior IC Quality Assurance Specialist (Manufacturing)
Builds
GMP-compliant drug products for biopharma clients
Domain
Biopharmaceutical Manufacturing / Quality Assurance
Required skills
GMP compliance, AQL visual inspection, batch record review, root cause analysis, deviation/CAPA initiation, SOP review, material disposition, environmental monitoring review, audit support, technical writing
Preferred skills
Lean operation excellence, FDA regulations (21CFR Part 210, 211 & 820), ICH regulations, Risk Management Tools (FMEA, HACCP, PHA), ASQ certification
Technologies
GMP documentation systems, Root Cause Analysis methodologies (fishbone, 5 whys)
Responsibilities
Perform real-time QA oversight of formulation and aseptic processes; conduct AQL visual inspection of finished drug product vials; review and approve batch records and incoming raw materials; initiate deviations, CAPA, and nonconformances; perform internal audits and walkthroughs; support client and regulatory inspections; coach personnel on cGMP compliance.
Seniority
Mid-Senior, hands-on IC
